Kornimate/medical-research-clean huggingface dataset:
canadian watchman registry

Conditions: Atrial Fibrillation

Summary: canadian watchman registry is a multicentre (8 centres) canadian prospective, non-randomized, registry to enrol 100 consecutive patients undergoing laa closure with the watchan device to study the safety and effectiveness of the watchman device

atrial fibrillation (af) is the most common cardiac arrhythmia with current prevalence estimated at 1.5-2% of the general population. af is a major cause of stroke, responsible for 15% of all strokes and 30% of strokes in patients age \>80. stroke is the leading cause of long-term disability and is the 4th leading cause of death in the us. anticoagulation is the mainstay therapy for preventing strokes in af with a 64% relative stroke reduction and 26% relative mortality benefit with warfarin therapy. warfarin or newer anticoagulation treatments (noac) have been associated with increased risk of major bleeding and therefore a significant proportion (30-50%) of eligible patients do not receive therapy due to perceived risk of bleeding. the need for newer therapy is therefore required and percutaneous left atrial appendage closure (laac) devices have been investigated for patients with high risk of stroke and contra-indication to long term oral anticoagulation therapy. the watchman device is one of the leading laa closure devices and with the most world-wide clinical experience. the investigators are running a multicentre (8 centres) canadian prospective, non-randomized, registry to enrol 100 consecutive patients undergoing laa closure with the watchan device to study the safety and effectiveness of the watchman device.

Eligibility criteria:
inclusion criteria: * age ≥18 years, and * chads2 ≥1 and/or chads-vasc ≥2, and * prior major bleeding (intracranial, gastrointestinal bleeding, intraocular, respiratory, genitourinary, retroperitoneal, pericardial, anemia requiring transfusions, etc.), or contraindications to long-term oac (hasbled ≥3, high fall risk, cerebral aneurysm, blood dyscrasias, aortic dissection, etc.), or failure of oac (stroke/tia while on oac) exclusion criteria: * presence of laa thrombus * severe untreated mitral stenosis (no prior valve replacement)

Keywords: left atrial appendage closure watchman device laa closure
comparison of telavancin and vancomycin for hospital-acquired pneumonia due to methicillin-resistant staphylococcus aureus

Conditions: Bacterial Pneumonia

Summary: study 0015 (nct00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.


Eligibility criteria:
inclusion criteria: * clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration. exclusion criteria: * received more than 24 hours of potentially effective systemic (iv, im or po) antibiotic therapy for gram-positive pneumonia immediately prior to randomization

Keywords: nosocomial pneumonia mrsa
safety and pharmacokinetics of ceftolozane/tazobactam in pediatric participants with nosocomial pneumonia (mk-7625a-036)

Conditions: Nosocomial Pneumonia

Summary: this is a phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (mk-7625a) in pediatric participants with nosocomial pneumonia (np).


Eligibility criteria:
inclusion criteria: * is hospitalized and anticipated to receive a minimum of 8 days of concomitant standard-of-care \[soc\] antibiotic therapy for proven or suspected np. * if male, is abstinent from heterosexual intercourse, or agrees to use contraception during the intervention period and for ≥30 days after the last dose of study intervention. * if female, is not pregnant or breastfeeding, or is not a woman of childbearing potential (wocbp), or is a wocbp using acceptable contraception, is a wocbp with negative urine or serum pregnancy test within 48 hours of the first dose of study intervention, or is abstinent from heterosexual intercourse. exclusion criteria: * has a documented history of any moderate or severe hypersensitivity (or allergic) reaction to any β-lactam antibacterial. * participants 3 months to \<18 years of age: has moderate to severe impairment of renal function, defined as an estimated creatinine clearance (crcl) \<50 ml/min/1.73 m2 based on the revised schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration. * participants \<3 months of age: has crcl \<20 ml/min/1.73 m2 based on the revised schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration. * is receiving or is anticipated to receive piperacillin/tazobactam while receiving ceftolozane/tazobactam or has received piperacillin/tazobactam within 24 hours prior to the first dose of ceftolozane/tazobactam. * has participated in any clinical study of a therapeutic investigational product within 30 days prior to the first dose of ceftolozane/tazobactam. * has previous participation in any study of ceftolozane or ceftolozane/tazobactam. * has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of study data. * has any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure or septic shock. * has active immunosuppression.
the performance of the mologic biomarker panel in infection

Conditions: Sepsis; Infection

Summary: this study is a prospective, single center, observational, cohort study of patients to determine whether the mologic biomarker panel can identify patients with infection from those without, including those with other reasons for inflammation (e.g. post-operative). it will also assess whether it has the potential to judge the severity of illness, prognosticate outcome and guide antibiotic therapy. the aim is to recruit patients who are "representative" of patients with suspected sepsis, uncomplicated infection, or non-infection related critical illness that require critical care intervention and assessment. this study is observational and will not alter patient management or the standard of care. the results from the investigational mologic biomarker panel and associated research assays will not be provided to treating clinicians, or used in any manner to affect patient care. the study will take place over approximately an 18-month period and it is anticipated that approximately 600 patients will be collectively enrolled. the study aims to recruit patients from three environments within uclh: * the emergency department. * critical care unit * patients undergoing major surgery


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * investigated for potential infection (the clinical need for a blood culture) exclusion criteria: * \<18 years old * severe anaemia (\<60g/dl) and contra-indication to transfusion * unable to gain consent or agreement * treated with palliative intent * blood culture indicated for screening or monitoring
dose-finding study of mt-1303

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: the primary objectives of the study are: * to evaluate the effects of three oral doses of mt-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (rrms) on mri parameters * to evaluate the safety and tolerability of three oral doses of mt-1303 compared to placebo given for a period of 24 weeks in subjects with rrms.


Eligibility criteria:
inclusion criteria: * rrms as defined by the revised mcdonald criteria * evidence of recent ms activity defined as either: * at least one documented relapse in the previous 12 months, or * a positive gadolinium (gd)-enhanced mri scan within 3 months prior to screening, or * at least two documented relapses in the previous 24 months with a positive gd-enhanced mri scan within the previous 12 months * expanded disability status score (edss) score ≥0.0 and ≤5.5 points. exclusion criteria: * primary progressive, secondary progressive or progressive relapsing ms at screening * disease duration \>15 years combined with an edss score ≤2.0 * relapse of ms during the screening period * history or known presence of other neurological disorders likely to render the subject unsuitable for the study * history of any of a list of pre-defined cardiovascular diseases * history or known presence of any significant central nervous system, infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study * previous exposure to any sphingosine 1-phosphate receptor modulator * receipt of a live vaccine or systemic corticosteroid use within 28 days prior to randomisation * previous treatment with beta-interferons or glatiramer acetate within 14 days prior to randomisation * previous treatment with intravenous immunoglobulin, plasmapheresis, certain immunosuppressants, lymphocyte-depleting therapy, total body irradiation or bone marrow transplantation * need, or likely need for, treatment with class i or iii anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate * evidence of significant anaemia, thrombocytopenia, leucopoenia or lymphocytopenia, renal or hepatic impairment * clinically significant electrocardiogram (ecg) findings.

Keywords: relapsing-remitting multiple sclerosis rrms
cardiomems hf system coverage with evidence development study

Conditions: Heart Failure

Summary: the purpose of the cardiomems ced study is to determine if pulmonary artery (pa) pressure-guided heart failure management using the cardiomems™ hf system improves long-term health outcomes in heart failure (hf) patients in the real-world setting.

the cardiomems ced study will assess 2-year hf hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the cardiomems hf system, as compared to a contemporaneous control of hf subjects managed without pa pressure-guidance.

Eligibility criteria:
inclusion criteria: 1. subject implanted with a cardiomems pressure sensor (treatment arm only) 2. subject \>=18 years of age at time of implant 3. subject has a history of acute decompensated hf or hf-related congestion defined by at least one of the following qualifying event types: hf hospitalization, elevated bnp/nt-probnp exclusion criteria: 1. subject has history of heart transplant or durable mechanical circulatory device 2. subject hospitalized with cardiogenic shock or sepsis 3. subject received prior pa pressure sensor implant (control arm only)
proof of concept study efficacy of an antacid/lansoprazole combination for relief of heartburn

Conditions: Heartburn

Summary: this study will investigate the safety and efficacy of an antacid/lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.


Eligibility criteria:
inclusion criteria: * experiencing heartburn in the past month if untreated * having heartburn that responds to heartburn medication * be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study. exclusion criteria: * having history of erosive esophagitis or gastroesophageal reflux disease (gerd) diagnosed by a physician and confirmed by testing (endoscopy) * be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study. "other protocol-defined inclusion/exclusion criteria may apply"

Keywords: heartburn antacid ppi lansoprazole calcium carbonate magnesium hydroxide relief of heartburn following ingestion of a heartburn-inducing meal
evaluating the treatment in the mzeb aachen

Conditions: Intellectual Disability; Disability Physical

Summary: evaluation of patient characteristics, involved physicians and therapists as well as therapies in a german university center for the treatment of patients with intellectual disabilities and severe multiple disability (mzeb aachen)

in the mzeb aachen, since 11/2018 patients with intellectual disabilities and/or severe multiple disabilities are diagnosed, treated and accompanied for many years in a multidisciplinary setting with physicians, nurses, physiotherapists, ergo therapists, speech therapists and support by social workers. mzebs are considered to have a pilot function in the health care system, cooperating with therapists and physicians in the surroundings. this concept is established as a new concept in germany in order to optimise health care for patients with disabilities. thus we want to investigate patient characteristics, diagnoses, involved physicians and therapists as well as proposed therapies and disease progress in this center.

Eligibility criteria:
inclusion criteria: * intellectual disability and/or severe multiple disability (disability degree gdb at least 70 and at least one noticeable sign * willing to participate exclusion criteria: * housed in an institution and/or prison
safety and efficacy of imatinib in chronic myelogenous patients older than 70 years

Conditions: Chronic Myeloid Leukemia

Summary: the aim of this phase ii trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. quality of life will be carefully assessed.

patients will received imatinib at a dose of 400mg daily. tolerability and quality of life will be assessed secondary objectives are : to evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points. duration of responses and failure to respond will be evaluated.

Eligibility criteria:
inclusion criteria: * cml ph+ (assessed by cytogenetic or fish) * chronic phase with less than 5% bone marrow blasts * diagnosis within 12 months * age ≥ 70 year at inclusion * ps grade 0 to 2 (ecog) * mini mental status more than 25 * hydroxyurea optional before imatinib * adequate end organ function, defined as the following: total bilirubin \<1.5x uln, sgpt \<3x uln, creatinine \<1.5x uln. exclusion criteria: * patients who cannot sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital * mini mental status ≤ 25 * patients who are not able to adequately take the study drug * age less than 70 y * accelerated or blastic phase * previous therapy with imatinib or interferon * hiv positivity

Keywords: cml - ederly patients - imatinib mesylate
study evaluating the clinical remission in early aggressive rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is an observational prospective, multicenter study. the aim of the study is to evaluate how the italian population of patients are treated with early aggressive ra, defined by the italian society of rheumatology guidelines, (giara registry study group. clin exp rheumatol 2003;21(suppl. 31):s129-s132), in rheumatologic clinical practice and whether recent scientific evidence or new treatments available to rheumatologists can change their practice in a 2 year follow-up. the observation will primarily focus on the disease activity and clinical remission in patients who are receiving different treatment strategies. the primary goal is to define prevalence of clinical remission, according to the (disease activity score) das 28 definition of clinical remission, in patients with early aggressive ra receiving different therapies at 1 year. secondary objective are assessment of: * prevalence of remission at the second year * disease activity at the first and second year. * acr 20%, 50%, 70% response at the first and second year. * quality of life in patients with or without remission at the first and second year * safety evaluations

it was expected that approximate 200 patients were enrolled in the study. have been enrolled 152 patients. a statistical analysis plan will contain a detailed description of criteria for valuable patients for analyses and a description of statistical analyses. in general, all patients who respond inclusion/exclusion criteria at baseline will be considered valuable for the study. the summaries will include descriptive statistics (mean, standard deviation, sample size) for the continuous parameters, and absolute frequencies and percentages for the remaining categorical parameters.

Eligibility criteria:
inclusion criteria: inclusion criteria based on clinical practice of aggressive ra * diagnosis of early aggressive ra in accordance with local guideline * disease duration \< 2 years and at least six months since onset of symptoms * patients naïve to anti-tnfa drugs and dmards, including mtx, or assuming one or more dmard without complete response exclusion criteria: exclusion criteria based on clinical practice of aggressive ra * patients should not be included in the study if they have participated in any interventional clinical trial within the previous 2 years.

Keywords: arthritis
phase ii study evaluating busulfan and fludarabine as preparative therapy in adults with hematopoietic disorders undergoing mud sct

Conditions: Chronic Myeloid Leukemia; Acute Myelogenous Leukemia; Myelodysplasia; Acute Lymphocytic Leukemia; Severe Aplastic Anemia; Non-Hodgkin's Lymphoma; Lymphoproliferative Disease; Multiple Myeloma; Advanced Myeloproliferative Disease

Summary: the primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the gvhd prophylaxis regimen. the goal is to demonstrate safety, aiming for a transplant related mortality rate (trm) of \ or equal to 60% will be considered unacceptable. another goal is to demonstrate efficacy by showing and overall survival of \>40% at 1-year following transplant.


Eligibility criteria:
inclusion criteria: * no fully or single-antigen mismatched sibling donor is available to donate stem cells. * age \>15 and \<61 * ecog ps \< or equal to 2 * adequate renal function with serum creatinine \<2.0 mg/dl * pulmonary diffusing capacity \>40% of predicted * cardiac ejection fraction \>40% as measured by radionuclide wall motion study or echocardiography * no active liver disease. total bilirubin must be \< or equal to 2.0 mg/dl. alkaline phosphatase and ast must be less than three times the upper limit of normal. patients with hepatitis c and active hepatitis b are eligible only if a liver biopsy is performed and there is \< or equal to grade 2 inflammation. patients wtih a history of hbv infection should be tested for hbeag, antihbe and hbv dna (quantitative). patients with active hbv viral replication should receive anti-viral therapy. * negative serology for the human immunodeficiency virus (hiv) * available hla-matched donor (see hla compatibility requirements below) * signed informed consent from the recipient exclusion criteria: * ongoing active infection * pregnancy and/or nursing * active, uncontrolled cns leukemia * opinion of bmt committee that autologous or mini-allogeneic transplant would be the preferable form of treatment * receipt of any chemotherapy within 3 weeks of study entry except for hydroxyurea or imatinib mesylate. use of interferon within 3 months of starting therapy.

Keywords: matched unrelated donor stem cell transplantation busulfan fludarabine hematopoietic disorder
adults regulating their weight everyday with mobile internet support

Conditions: Obesity

Summary: adults regulating their weight everyday with mobile internet support (artemis) is a randomised controlled trial evaluating the effectiveness of a mobile app based weight loss intervention designed to increase self-regulation in adults living with obesity.

adults regulating their weight everyday with mobile internet support (artemis) is a randomised, controlled trial examining the effectiveness of the self-regulation intervention to promote weight loss, when delivered through a mobile application, with no in-person contact, among a sample of \~ 1,294 adults living with obesity in the united kingdom. further, the investigators will assess the safety of the intervention regarding any a potential unintended consequence, which is the development of disordered eating. the intervention comprises daily self-weighing and daily reflection on the day's task of controlling weight through implementation of actions, and selection of new actions for the next day. it encourages users to build up a repertoire of actions for life that suit them in controlling weight.

Eligibility criteria:
participation is open to those who meet the following eligibility criteria: * aged ≥ 18 years; * living with obesity (bmi ≥ 30 if of white ethnicity; ≥ 27.5 for all other ethnic groups); * full- time residents in the uk, without the intention to move outside the uk within the next 12 months; * able to access the internet with a smartphone; * able to access and use a digital weighing scale; * can understand english; * not presently signed up with an intention to attend, or have in the previous three months attended, a weight management programme; * not currently participating in another weight management study; * not lost \> 5 kg (10 pounds) body weight in the previous six months; * not undergone bariatric surgery, or presently scheduled to have bariatric surgery; * not pregnant, or planning a pregnancy in the next 12 months; * not previously been diagnosed with an eating disorder; * not recently been diagnosed with a disease, or expected to undergo treatment for a disease, associated with substantial weight loss e.g., cancer treatment.

Keywords: obesity digital intervention mobile app self-regulation weight loss